Omega-3 Supplementation and Depression Clinical Trial

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Women who met the trial inclusion criteria were recruited from clinic registers at their respective Prevention of mother-to-child transmission program clinics from July 2012 to May 2013 with assistance from mentor-mothers in the clinics. Women visiting the clinics first time were included in clinic registers and invited to participate in the trial.

Pre-assignment Details

Participants were assigned to either of the trial arms soon after enrollment to minimize drop-outs which might have occurred if enrolled participants exceeded gestation age or gave birth before randomization.

Arm/Group Title

Soybean Oil Soft Gels Control Group

Fish Oil Omega-3 EPA-rich Experimental Group

Arm/Group Description

As a control group, participants re...

As the experimental group, particip...

Arm/Group Description

As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.

Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.

As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.

Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.

Period Title: Overall Study

Started

107 [1]

109 [2]

At Week-4

98 [2]

92 [2]

At Week-8 (End of Study Period)

96 [3]

86 [3]

Completed

96 [4]

86 [4]

Not Completed

11

23

Reason Not Completed

Lost to Follow-up

11

23

[1]

Participants received every two-weeks supply and monitored regularly on cell-phone and face-to-face.

[2]

Participants received every two-week supply and monitored regularly on cell-phone and face-to-face.

[3]

End of study data collected for all participants who completed the 8-week trial period.

[4]

End of study data analyzed for only participants who completed the 8-week trial period.

As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.

Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.

As the intervention group, participants received a dietary supplement of Omega Via fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits to resupply the soft-gels, monitoring of side effects and compliance and data collection.

Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Each participants took three soft gels of fish oil omega-3 fatty acid per day, each containing more EPA (0.715 grams) than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.

Total of all reporting groups

Overall Number of Baseline Participants

107

109

216

Baseline Analysis Population Description

[Not Specified]

Baseline Analysis Population Description

[Not Specified]

Age, Categorical

Measure Type: Count of Participants

Unit of measure: Participants

Number Analyzed

107 participants

109 participants

216 participants

<=18 years

5

4.7%

5

4.6%

10

4.6%

Between 18 and 65 years

102

95.3%

104

95.4%

206

95.4%

>=65 years

0

0.0%

0

0.0%

0

0.0%

Age, Continuous

Median (Inter-Quartile Range)

Unit of measure: Years

Number Analyzed

107 participants

109 participants

216 participants

26

(22 to 30)

26

(22 to 30)

26

(22 to 30)

Sex: Female, Male

Measure Type: Count of Participants

Unit of measure: Participants

Number Analyzed

107 participants

109 participants

216 participants

Female

107

100.0%

109

100.0%

216

100.0%

Male

0

0.0%

0

0.0%

0

0.0%

Region of Enrollment

Measure Type: Number

Unit of measure: Participants

Kenya

Number Analyzed

107 participants

109 participants

216 participants

107

109

216

Gestation age

Median (Inter-Quartile Range)

Unit of measure: Weeks

Number Analyzed

107 participants

109 participants

216 participants

22

(19 to 24)

22

(18 to 24)

22

(18 to 24)

Cluster of differentiation 4 (CD4) cell count

Median (Inter-Quartile Range)

Unit of measure: Cells/µl

Number Analyzed

107 participants

109 participants

216 participants

360

(288 to 414)

361

(287 to 440)

360

(288 to 425)

Mid-upper-arm circumference (MUAC)

Median (Inter-Quartile Range)

Unit of measure: Cm

Number Analyzed

107 participants

109 participants

216 participants

26.0

(24.3 to 28.0)

26.0

(23.9 to 27.6)

26.0

(24.0 to 27.8)

BDI-II depressive symptom scores
[1]

Median (Inter-Quartile Range)

Unit of measure: Scores on a scale

Number Analyzed

107 participants

109 participants

216 participants

21

(17 to 25)

20

(16 to 25)

21

(17 to 25)

[1]

Measure Description: Beck Depression Inventory Second Edition (BDI-II) Scale is a 21-item scoring tool which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe).Scores for each symptom are added up to obtain the total scores for all 21 items, which are interpreted as follows: Scores of 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression and 29-63: severe depression.

Marital status

Measure Type: Number

Unit of measure: Participants

Number Analyzed

107 participants

109 participants

216 participants

Single (not married, divorced, widowed

22

27

49

Married

85

82

167

Parity

Measure Type: Number

Unit of measure: Participants

Number Analyzed

107 participants

109 participants

216 participants

First pregnancy

24

24

48

Not first pregnancy

83

85

168

Education status

Measure Type: Number

Unit of measure: Participants

Number Analyzed

107 participants

109 participants

216 participants

No High school education

55

55

110

At least High school education

52

54

106

Employment status

Measure Type: Number

Unit of measure: Participants

Number Analyzed

107 participants

109 participants

216 participants

Not in gainful employment

64

61

125

In gainful employment with income

43

48

91

Household income per month

Median (Inter-Quartile Range)

Unit of measure: Kenya Shillings (Ksh.)

Number Analyzed

107 participants

109 participants

216 participants

5025

(3000 to 8000)

6000

(3000 to 8000)

5050

(3000 to 8000)

HIV status knowledge before pregnancy

Measure Type: Number

Unit of measure: Participants

Number Analyzed

107 participants

109 participants

216 participants

No, newly tested less than 6 months

56

56

112

Yes, known positive, 6 months plus

51

53

104

HIV status disclosure to anyone

Measure Type: Number

Unit of measure: Participants

Number Analyzed

107 participants

109 participants

216 participants

Not disclosed

25

18

43

Disclosed to someone

82

91

173

prevention of mother-to-child transmission program m2m support group meeting attendance

Depressive symptoms were assessed by Beck Depression Inventory Second Edition (BDI-II) Scoring scale at Baseline and end of study during the 8- week study period. The BDI-II Scale is a 21-item scoring tool which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represent a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe).Scores for each symptom are added up to obtain the total scores for all 21 items, which are interpreted as follows: Scores of 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression and 29-63: severe depression. The change in BDI-II scores were computed from post-intervention scores at week 8 and baseline BDI-II scores at week 0.

Time Frame

8 weeks

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Only participants who completed the 8-weeks trial period were included in the final analysis of primary outcome. Per protocol analysis Post-intervention BDI-II scores at week 8 minus baseline BDI-II scores at week 0

Arm/Group Title

Soybean Oil Soft Gels Control Group

Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group

Arm/Group Description:

As a control group, participants re...

As the experimental group, particip...

Arm/Group Description:

As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.

Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.

As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.

Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.

Null hypothesis: There is no difference in the magnitude of change in BDI-II scores between HIV–seropositive pregnant women on fish oil omega-3 EPA-rich supplements and the control group on soybean oil soft gels. A sample size of 91 women per arm gave an 85% power to detect as statistically significant at 5% level, a true difference of 4 scores in the mean depressive symptom scores between the two arms assuming a within group standard deviation of nine in depressive symptom scores.

Type of
Statistical Test

Superiority or Other

Comments

[Not Specified]

Statistical Test of Hypothesis

P-Value

0.21

Comments

The p-value was adjusted for baseline variations in the analysis of covariance (ANCOVA) regression model. The significance level was set at p-value less than 0.05.

Method

ANCOVA

Comments

In ANCOVA, fish oil group was main effect, participant baseline variables were covariates and presence of interaction between covariates was tested.

Both known and unknown possible Adverse Events were closely monitored through out the eight-weeks study period for each participant by phone or face-to-face individual interviews and observations.

Adverse Event Reporting Description

[Not Specified]

Arm/Group Title

Soybean Oil Soft Gels

Fish Oil Omega-3 EPA-rich Soft Gels

Arm/Group Description

Participants on this arm received a...

Participants received OmegaVia fish...

Arm/Group Description

Participants on this arm received a dietary supplement of OmegaVia soybean oil soft gels as a placebo for 8 weeks with bi-weekly follow-up visits to monitor side effects and compliance.

Soybean oil soft gels: Each participant received OmegaVia soybean oil soft gels to take orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks.

Participants received OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight (8) weeks with bi-weekly follow-up visits for monitoring of side effects and compliance and data collection.

Fish oil omega-3 EPA-rich soft gels: A total of 3.0g of OmegaVia fish oil omega-3 EPA-rich soft gels was taken orally per day as one soft gel in the morning, mid-day and evening after meals for 8 weeks with bi-weekly follow-up visits.

All-Cause Mortality

Soybean Oil Soft Gels

Fish Oil Omega-3 EPA-rich Soft Gels

Affected / at Risk (%)

Affected / at Risk (%)

Total

--/--

--/--

Serious Adverse Events Serious Adverse Events

Soybean Oil Soft Gels

Fish Oil Omega-3 EPA-rich Soft Gels

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/107 (0.00%)

0/109 (0.00%)

Other (Not Including Serious) Adverse Events Other (Not Including Serious) Adverse Events

Frequency Threshold for Reporting Other Adverse Events

0%

Soybean Oil Soft Gels

Fish Oil Omega-3 EPA-rich Soft Gels

Affected / at Risk (%)

Affected / at Risk (%)

Total

15/107 (14.02%)

24/109 (22.02%)

Blood and lymphatic system disorders

Nose Bleeding once † [1]

0/107 (0.00%)

1/109 (0.92%)

Gastrointestinal disorders

Nausea with fishy-after-taste † [2]

5/107 (4.67%)

10/109 (9.17%)

Occasional vomitting in the morning after taking soft gel † [2]

3/107 (2.80%)

6/109 (5.50%)

Occasional heartburn † [2]

5/107 (4.67%)

3/109 (2.75%)

Occasional bloated stomach † [2]

0/107 (0.00%)

2/109 (1.83%)

Occasional loose stool † [2]

1/107 (0.93%)

0/109 (0.00%)

Skin and subcutaneous tissue disorders

Occasional itchy skin † [2]

1/107 (0.93%)

2/109 (1.83%)

†

Indicates events were collected by systematic assessment

[1]

This was reported only once by one participant. Data was collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.

[2]

Data collected throughout the 8-week study period through cell-phone regular contacts and face-to-face interviews and observations.